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FENTANYL TRANSDERMAL SYSTEM

All products: not a benefit

Duragesic 12 · PIN 09858350 · 12mcg/hr · Trans Patch

Listed, not a benefitOntario PIN; no Health Canada record under this code

StatusListed, not a benefit

Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives

Patient paysPatient pays: program not supplied; amount cannot be determined.

No Health Canada record under this code: Ontario lists it under a product identification number (PIN), not a DIN. Look up the brand's own DIN on Health Canada: https://health-products.canada.ca/dpd-bdpp/index-eng.jsp

Check Health Canada brand search

Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ontario Limited Use criteria — code 689

Reason for Use code 689 For the treatment of chronic pain in patients who have been stabilized on fentanyl and require the use of fentanyl 12mcg/hr patches for dose adjustment up or down to the lowest optimal opioid dose. Coverage limit: LU Authorization Period: 1 year

1 brand, same coverage

Duragesic 12 · DIN 09858350 Manufacturer: Janssen-Ortho Inc.; listing date 2024-09-27 No Health Canada record under this code: Ontario lists it under a product identification number (PIN), not a DIN. Look up the brand's own DIN on Health Canada: https://health-products.canada.ca/dpd-bdpp/index-eng.jsp

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Duragesic 12: Formulary list price not recorded/unit (unit not stated in source; not the patient's cost)

Formulary data: Ontario extract of Aug 26, 2026 · Ontario PIN; see Health Canada brand lookup · Verify on the e-Formulary ↗ (DIN 09858350)

Source record

DIN 09858350: Duragesic 12 Raw flags: notABenefit=Y, sec3=Y Item: 280808469; group id 403; item number 0962; lccId 00403; manufacturer id JNO Source form: Trans Patch; strength: 12mcg/hr Recorded listing: Listed, not a benefit; ODB pays only for the benefit products in this interchangeable category Source prices (unrounded): not recorded; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=09858350 Look up the brand's own DIN on Health Canada: https://health-products.canada.ca/dpd-bdpp/index-eng.jsp

Interchangeable products

Sandoz Fentanyl Patch · DIN 09858348 · $3.3200 Teva-Fentanyl · DIN 09858349 · $3.3200

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=09858350

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Other drugs in the same formulary class (28:08:08 Opiate Agonists) and how they are covered

Matched class: 28:08:08 Opiate Agonists

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Some products covered without a code (check the product listing): ACETAMINOPHEN & CAFFEINE & CODEINE PHOSPHATE, ACETAMINOPHEN & CODEINE PHOSPHATE, CODEINE PHOSPHATE, HYDROMORPHONE HCL, METHADONE HCL, MORPHINE SULFATE, OXYCODONE HCL & ACETAMINOPHEN, OXYCODONE HCL & ACETYLSALICYLIC ACID 28:08:08 Opiate Agonists

ACETAMINOPHEN & CAFFEINE & CODEINE PHOSPHATE

· 4 products · General benefit (2), Listed, not a benefit (2) · strengths: 300mg & 15mg & 15mg, 300mg & 15mg & 30mg · Tab

ACETAMINOPHEN & CODEINE PHOSPHATE

· 6 products · General benefit (3), Listed, not a benefit (3) · strengths: 160mg & 8mg/5mL, 300mg & 30mg, 300mg & 60mg · O/L, Tab

CODEINE PHOSPHATE

· 3 products · General benefit (2), Listed, not a benefit (1) · strengths: 15mg, 30mg · Tab

HYDROMORPHONE HCL

· 28 products · General benefit (21), Listed, not a benefit (3), General benefit; DIN status E (meaning unconfirmed); confirm discontinuation/availability with Health Canada (4) · strengths: 4.5mg, 9mg, 3mg, 6mg, 12mg, 18mg, 2mg/mL, 10mg/mL, 1mg/mL, 1mg, 2mg, 4mg, 8mg · CR Cap, Inj Sol-1mL Pk, Oral Sol, Tab

METHADONE HCL

· 16 products · General benefit (8), Off-Formulary Interchangeable, not an ODB benefit (8) · strengths: 10mg/mL, 1mg, 5mg, 10mg, 25mg · Oral Concentrate, Oral Concentrate (Cherry Flavour), Oral Concentrate (Unflavoured), Tab

MORPHINE SULFATE

· 35 products · General benefit (31), Listed, not a benefit (1), Off-Formulary Interchangeable, not an ODB benefit (3) · strengths: 10mg, 15mg, 30mg, 60mg, 100mg, 2mg/mL, 10mg/mL, 15mg/mL, 50mg/mL, 20mg, 50mg, 200mg, 5mg · ER Cap, Inj Sol Amp, Inj Sol-1mL Pk, SR Cap, SR Tab, Tab

OXYCODONE HCL & ACETAMINOPHEN

· 5 products · General benefit (4), Listed, not a benefit (1) · strengths: 5mg & 325mg · Tab

OXYCODONE HCL & ACETYLSALICYLIC ACID

· 2 products · General benefit (1), Listed, not a benefit (1) · strengths: 5mg & 325mg · Tab

CODEINE SULFATE TRIHYDRATE & MONOHYDRATE

· 4 products · Limited Use, codes 201 · strengths: 50mg, 100mg, 150mg, 200mg · CR Tab

ACETYLSALICYLIC ACID & BUTALBITAL & CAFFEINE

· 3 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 330mg & 50mg & 40mg · Cap

ACETYLSALICYLIC ACID & BUTALBITAL & CAFFEINE & CODEINE PHOSPHATE

· 6 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 330mg & 50mg & 40mg & 15mg, 330mg & 50mg & 40mg & 30mg · Cap

OXYCODONE HCL

· 9 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 5mg, 10mg, 20mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 28:08:08 and 2 more

Full class listing Related classes: 28:08:04 Nonsteroidal Anti-Inflammatory Agents, 28:08:12 Opiate Partial Agonists, 28:08:92 Miscellaneous Analgesics and Antipyretics, 28:16:04 Antidepressants, 28:16:08 Tranquilizers, 28:16:12 Other Psychotropics, 28:36:08 Anticholinergic Agents, 28:36:20 Dopamine Receptor Agonists Same formulary class, not same indication: class membership alone does not establish equivalent uses.

What the Health Canada label says it is for

INDICATIONS AND CLINICAL USE Adults: TEVA-FENTANYL (fentanyl transdermal system) is indicated for the management of pain severe enough to require daily, continuous, long-term opioid treatment and:  that is opioid-responsive;  and for which alternative options are inadequate Only for use in patients who are already receiving opioid therapy at a total daily dose of at least 60 mg/day Morphine Equivalents. TEVA-FENTANYL is not indicated as an as-needed (prn) analgesic. The initial dose of TEVA-FENTANYL should be obtained or calculated from the conversion tables (see DOSAGE AND ADMINISTRATION), and must not be higher than that dose which is equivalent to the total dose of opioids the patient is receiving at the time of the switch to the patch. Because serious or life-threatening hypoventilation could occur, TEVA-FENTANYL should not TEVA-FENTANYL (12, 25, 50, 75 and 100 mcg/h) Page 3 of 60 be used in:  non-opioid-tolerant patients  the management of post-operative pain Pediatrics (< 18 years of age): The safety and efficacy of fentanyl transdermal system has not been studied in the pediatric population. Therefore, the… https://pdf.hres.ca/dpd_pm/00066268.PDF PM date: June 10, 2022 Source product: TEVA-FENTANYL; DIN 02282941; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Other review policies

For Duragesic 12: no applicable EAP criteria are held and no ODB benefit is established. These policies do not establish coverage.

For rare, immediately life-, limb- or organ-threatening circumstances, the Compassionate Review Policy may consider an unfunded drug or indication, subject to its criteria and without bypassing the drug review process. Compassionate Review Policy

Compassionate Review Policy: source quote

Where there are rare clinical circumstances in immediately life, limb, or organ-threatening conditions, the Executive Officer will also consider requests for drugs or indications in situations where there has not been a decision by the Executive Officer to provide funding of the drug or indication as part of the Ontario Drug Benefit program (and the EAP), and the drug or indication requested would not circumvent the established review process for new drugs or indications as part of the drug submission process for listing within the Ontario Drug Benefit program. Requests must meet the criteria for the Compassionate Review Policy.

Ontario source; updated September 15, 2026

For cancer drugs, Case-by-Case Review considers rare, immediately life-threatening circumstances when no satisfactory funded treatment exists; its criteria and application process apply. Case-by-Case Review (cancer drugs)

Case-by-Case Review (cancer drugs): source quote

Note: Requests for cancer drugs are considered under the Case-by-Case Review Program (CBCRP) which is administered by Ontario Health (Cancer Care Ontario) on behalf of the Ministry of Health. The CBCRP considers funding requests for drugs (both oral therapies and injectable drugs) for the treatment of cancer in patients who have a rare clinical circumstance that is immediately life-threatening (death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and funded treatment. Please refer to the Ontario Health website for information on the application process, FAQs, eligibility criteria and program policies.

Ontario source; updated September 15, 2026